Dissociative DisorderTCC-DISSONCT06917209
Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy
A study testing CBT-CD psychotherapy in people with Dissociative Disorder, run by University Hospital, Tours at 8 sites in France.
Trial summary
Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dissociative Disorder
- What is being tested?
- CBT-CD psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesFrance
- Study dates
- 16 May 2025to 16 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Membership of a social security scheme
- Participant's express consent
- Have at least one diagnosis of dissociative disorder among the following:
- depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder.
- Be able to carry out psychotherapy sessions.
- If taking psychiatric medication, treatment must have been stable for at least 30 days.
Who cannot join
- Present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder.
- Present cognitive deficits.
- Be engaged in psychotherapeutic work.
- Be undergoing benzodiazepine treatment.
- Pregnant women and breastfeeding women
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Psychiatrie / CHU ANGERS
Angers
François KAZOUR, MD-PhD
François KAZOUR, MD-PhD
- Not yet recruiting
Centre régional du Psychotraumatisme des Hauts de France / CHU LILLE
Lille
Arnaud LEROY, MD-PhD
Arnaud LEROY, MD-PhD
- Not yet recruiting
Urgences psychiatrique / CHU MONTPELLIER
Montpellier
Matthieu FRAIGNEAU, MD
Matthieu FRAIGNEAU, MD
- Not yet recruiting
Unité de neuromodulation en psychiatrie / CHU NANTES
Nantes
Anne SAUVAGET, MD-PhD
Anne SAUVAGET, MD--PhD
- Not yet recruiting
Centre départemental de Psychotraumatologie (unité TCC) / ORLEANS
Orléans
Sophie LAPUJOULADE, MD
Sophie LAPUJOULADE, MD
- Not yet recruiting
Centre Régional du Psychotraumatisme du Grand Est / CHU STRASBOURG
Strasbourg
Arnaury MENGIN, MD
Arnaury MENGIN, MD
- Recruiting
Centre Régional du Psychotraumatisme CRP / CHRU TOURS
Tours
Lyna CHAMY, MD
Lyna CHAMY, MD
- Recruiting
Unité de Neuromodulation / CHU de Tours
Tours
Wissam EL HAGE, MD-PhD
Wissam EL HAGE, MD
About this study
Official title: Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Among these studies, dissociation-focused cognitive behavioral therapy (DF-CBT) seems promising. DF-CBT is based on a solid empirical model that has received numerous scientific evidence.
- Conditions
- Dissociative Disorder
- Being tested
- CBT-CD psychotherapy
- Medical subject headings
- Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-CD psychotherapyOther
9 weekly sessions of CBT-CD psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy. | Experimental | Not described Receives: Other: CBT-CD psychotherapy |
| The control group will receive 9 weekly relaxation sessions. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Dissociative Experience Scale (DES)
Difference in Dissociative Experience Scale (DES) between randomization and 3 months after.
The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.
Measured: Between randomization and 3 months after
Secondary outcomes (6)
Hetero-administered visual analogue scale
Visual analogue scales in which the practitioner rates the intensity of the patient's dissociative symptoms on the basis of his/her clinical assessment.
Measured: At randomization, 3 months and 6 months after
Dissociation Questionnaire (DIS-Q)
The Dissociation Questionnaire is a 63-item questionnaire measuring dissociative-trait manifestations. Participants respond to each item using a 5-point Likert scale. Four sub-scores (loss of control, absorption, amnesia and identity confusion) are calculated.
Measured: At randomisation, 3 months and 6 months after
Hospital Anxiety Depression Scale (HADS)
Hospital Anxiety Depression Scale (HADS) is a 14-item self-report questionnaire. Two sub-scores (anxiety and depression) are calculating.
Both scores range between 0 and 21 with 0 corresponding to the ideal score (no anxiety or depression symptoms).
Measured: Randomization, 3 months and 6 months after
Post traumatic stress disorder checklist scale (PCL-5)
The post traumatic stress disorder checklist scale (PLC-5) is 20-item scale to assess post-traumatic stress symptoms. Participants respond to each item using a 5-point Likert scale. The score ranges between 0 and 80, with 0 reflecting no post traumatic stress disorder.
Measured: Randomization, 3 months and 6 months after
Satisfaction With Life Scale (SWLS)
The Satisfaction With Life Scale (SWLS) is a 5-item questionnaire assessing quality of life. Participants respond to each item using a 7-point Likert scale. The score range bewteen 0 and 35 with 35 reflects an extreme satisfaction with life.
Measured: Randomization, 3 months and 6 months after
Dissociative Experiences Scale (DES)
The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.
Measured: At 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start16 May 2025
- Primary completion16 Nov 2028 (estimated)
- Study completion16 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissociative DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis VANCAPPEL, PhD, Study chair, Unité de Neuromodulation / CHU de ToursWissam EL HAGE, MD-PhD, Principal investigator, Unité de Neuromodulation / CHU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917209
- Sponsor's protocol ID
- DR240330
- Acronym
- TCC-DISSO
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06917209
- Acronym / sponsor ID
- TCC-DISSO / DR240330
- Conditions
- Dissociative Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 16 Nov 2028 (estimated)
- Study completion
- 16 May 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Among these studies, dissociation-focused cognitive behavioral therapy (DF-CBT) seems promising. DF-CBT is based on a solid empirical model that has received numerous scientific evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy. | Experimental | Other: CBT-CD psychotherapy |
| The control group will receive 9 weekly relaxation sessions. | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 18 years
- Membership of a social security scheme
- Participant's express consent
- Have at least one diagnosis of dissociative disorder among the following:
- depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder.
Key exclusion criteria (5 listed)
- Present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder.
- Present cognitive deficits.
- Be engaged in psychotherapeutic work.
- Be undergoing benzodiazepine treatment.
- Pregnant women and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-CD psychotherapy9 weekly sessions of CBT-CD psychotherapy | Other | The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy. |
Primary outcome
Difference in Dissociative Experience Scale (DES)
Time frame: Between randomization and 3 months after
Difference in Dissociative Experience Scale (DES) between randomization and 3 months after. The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.
6 secondary outcomes
Hetero-administered visual analogue scale
Time frame: At randomization, 3 months and 6 months after
Dissociation Questionnaire (DIS-Q)
Time frame: At randomisation, 3 months and 6 months after
Hospital Anxiety Depression Scale (HADS)
Time frame: Randomization, 3 months and 6 months after
Post traumatic stress disorder checklist scale (PCL-5)
Time frame: Randomization, 3 months and 6 months after
Satisfaction With Life Scale (SWLS)
Time frame: Randomization, 3 months and 6 months after
Dissociative Experiences Scale (DES)
Time frame: At 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Related trials for Dissociative Disorder
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Not yet recruiting
Clinical Hypnosis Versus Guided Imagery for Dissociative Symptoms in Adults
Dissociative Symptoms
RecruitingPhase 3
Morphine or Ketamine for Analgesia
Abdominal Pain, Isolated Extremity Fracture
Recruiting
EXercise-induced PhysioLogical Adaptations In Neurological Disorders
Epilepsy, Functional Neurological Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexis VANCAPPEL, PhD study chair
Unité de Neuromodulation / CHU de Tours
Wissam EL HAGE, MD-PhD principal investigator
Unité de Neuromodulation / CHU de Tours
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-CD psychotherapy in people with Dissociative Disorder, run by University Hospital, Tours at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis VANCAPPEL, PhD (02.34.37.89.47, alexis.vancappel@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Dissociative Experience Scale (DES) (time frame: Between randomization and 3 months after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.